Multicenter Evaluation of the Fully Automated PCR-Based Idylla EGFR Mutation Assay on Formalin-Fixed, Paraffin-Embedded Tissue of Human Lung Cancer.

Before initiating treatment of advanced non-small-cell lung cancer with tyrosine kinase inhibitors (eg, erlotinib, gefitinib, osimertinib, and afatinib), which inhibit the catalytic activity of epidermal growth factor receptor (EGFR), clinical guidelines require determining the EGFR mutational status for activating (EGFR exons 18, 19, 20, or 21) and resistance (EGFR exon 20) mutations. The EGFR resistance mutation T790M should be monitored at cancer progression. The Idylla EGFR Mutation Assay, performed on the Idylla molecular diagnostics platform, is a fully automated (<2.5 hours turnaround time) sample-to-result molecular test to qualitatively detect 51 EGFR oncogene point mutations, deletions, or insertions. In a 15-center evaluation, Idylla results on 449 archived formalin-fixed, paraffin-embedded tissue sections, originating from non-small-cell lung cancer biopsies and resection specimens, were compared with data obtained earlier with routine reference methods, including next-generation sequencing, Sanger sequencing, pyrosequencing, mass spectrometry, and PCR-based assays. When results were discordant, a third method of analysis was performed, when possible, to confirm test results. After confirmation testing and excluding invalids/errors and discordant results by design, a concordance of 97.6% was obtained between Idylla and routine test results. Even with <10 mm2 of tissue area, a valid Idylla result was obtained in 98.9% of the cases. The Idylla EGFR Mutation Assay enables sensitive detection of most relevant EGFR mutations in concordance with current guidelines, with minimal molecular expertise or infrastructure.

Evaluation of a Specialized Yoga Program for Persons Admitted to a Complex Continuing Care Hospital: A Pilot Study.

Introduction. The purpose of this study was to evaluate a specialized yoga intervention for inpatients in a rehabilitation and complex continuing care hospital. Design. Single-cohort repeated measures design. Methods. Participants (N = 10) admitted to a rehabilitation and complex continuing care hospital were recruited to participate in a 50-60 min Hatha Yoga class (modified for wheelchair users/seated position) once a week for eight weeks, with assigned homework practice. Questionnaires on pain (pain, pain interference, and pain catastrophizing), psychological variables (depression, anxiety, and experiences with injustice), mindfulness, self-compassion, and spiritual well-being were collected at three intervals: pre-, mid-, and post-intervention. Results. Repeated measures ANOVAs revealed a significant main effect of time indicating improvements over the course of the yoga program on the (1) anxiety subscale of the Hospital Anxiety and Depression Scale, F(2,18) = 4.74, p < .05, and ηp2 = .35, (2) Self-Compassion Scale-Short Form, F(2,18) = 3.71, p < .05, and ηp2 = .29, and (3) Magnification subscale of the Pain Catastrophizing Scale, F(2,18) = 3. 66, p < .05, and ηp2 = .29. Discussion. The results suggest that an 8-week Hatha Yoga program improves pain-related factors and psychological experiences in individuals admitted to a rehabilitation and complex continuing care hospital.

Influenza antiviral resistance in the Asia-Pacific region during 2011.

Despite greater than 99% of influenza A viruses circulating in the Asia-Pacific region being resistant to the adamantane antiviral drugs in 2011, the large majority of influenza A (>97%) and B strains (∼99%) remained susceptible to the neuraminidase inhibitors oseltamivir and zanamivir. However, compared to the first year of the 2009 pandemic, cases of oseltamivir-resistant A(H1N1)pdm09 viruses with the H275Y neuraminidase mutation increased in 2011, primarily due to an outbreak of oseltamivir-resistant viruses that occurred in Newcastle, as reported in Hurt et al. (2011c, 2012a), where the majority of the resistant viruses were from community patients not being treated with oseltamivir. A small number of influenza B viruses with reduced oseltamivir or zanamivir susceptibility were also detected. The increased detection of neuraminidase inhibitor resistant strains circulating in the community and the detection of novel variants with reduced susceptibility are reminders that monitoring of influenza viruses is important to ensure that antiviral treatment guidelines remain appropriate.

Is there an increased maternal-infant prevalence of Factor V Leiden in association with severe pre-eclampsia?

OBJECTIVE: To compare the prevalence of the Factor V Leiden mutation in children and maternal-infant pairs in pregnancies affected by severe pre-eclampsia with unmatched normal controls. DESIGN: Prospective cohort study. SETTING: Department of Women's and Children's Health, The Canberra Hospital, Garran, ACT, Australia. SAMPLE: Forty-eight maternal-infant pairs where the index pregnancy was affected by severe pre-eclampsia; 46 unmatched maternal-infant pairs where the index pregnancy was defined as normal. METHODS: DNA analysis of cheek swab samples obtained from maternal-infant pairs for the Factor V Leiden mutation. MAIN OUTCOME MEASURE: The prevalence of the Factor V Leiden mutation in mothers, infants and maternal-infant pairs in association with severe pre-eclampsia compared with unmatched controls. RESULTS: No difference was detected in the prevalence of Factor V Leiden mutation between the women and children of both groups, nor the maternal-infant pairs from each group. CONCLUSIONS: No evidence was found of an increased prevalence of the Factor V Leiden mutation in either the mothers or children in association with severe pre-eclampsia. This result argues against a Factor V Leiden fetal or maternal contribution to the development of severe pre-eclampsia.